Bone anchor delivery system device with sutures

ABSTRACT

The device ( 10 ) has a handle assembly ( 40 ) and a bone anchor driver assembly ( 20 ). The handle assembly ( 40 ) has an upper handle portion ( 50 ) and a lower handle portion ( 60 ). The upper or lower handle portion is rotatable relative to the other handle portion. A bone anchor driver assembly ( 20 ) is for rotatably driving a bone anchor ( 12 ) into a hole in a bone. The bone anchor driver assembly ( 20 ) is fixed to one of either the upper or lower handle portions ( 50  or  60 ).

TECHNICAL FIELD

The present invention relates to methods and instruments for fixation ofsutures and tissue to bone, more particularly to a bone anchor systemfor securing sutures for attachment of soft tissue like ligament andcartilage to bone.

BACKGROUND OF THE INVENTION

The use of bone screw anchors to hold sutures is a widely acceptedpractice in shoulder or knee repair and fixation of soft tissue such asligaments, cartilage and tendons to bone. Ideally the suture anchor iseasy to install and provides a solid reliable way to fix the sutures tothe bone. The bone has a hard outer cortical shell with a softerunderlying region of cancellous bone tissue. The anchor must holdsutures after thousands of repetitive motions tensioning and relaxationuntil the ligament or tendon repair has time to heal and secure itselfto the bone and muscle tissue.

Older style bone anchors had an external eyelet to allow the sutures tobe fed through after the screw was driven into the bone. This left theeyelet exposed in the soft muscle tissue.

Later versions of bone anchors have the sutures inserted inside thescrew tip well inside the bone. This allows the screw outer end to stayflush with the cortical bone outer surface. The sutures can pass insidein some hollow screws from the tip to the outer surface. A main problemis how to thread the bone anchor into the bone. In some suture anchorsystems there is a self-driving feature that has a punch tip that can bemalleted into the bone. Once started, the anchor must be rotated tothread it into the bone. The ends of the sutures are often dangling inthe way.

Ideally the procedure should insure the bone anchor is easily installedwithout having the sutures interfering with the anchoring.

The present invention provides a threaded bone anchor that is easy toinstall wherein the sutures are held securely with the bone anchor, butwherein the ends of the sutures are contained inside the deliverydevice.

SUMMARY OF THE INVENTION

A bone anchor delivery system device has a handle assembly and a boneanchor driver assembly. The handle assembly has an upper handle portionand a lower handle portion. The upper and lower handle portions arerotatable relative to the other. The bone anchor driver assemblyprovides for rotatably driving a bone anchor. The bone anchor driverassembly is fixed to one of said upper or lower handle portions. Thehandle assembly rotation of one of the handle portions is fixed to thedriver allowing the other handle portion to be held non-rotatably forstabilization of the device. Preferably, the upper handle portion isfixed to the driver assembly. The upper handle portion also has animpact end for receiving blows from a mallet and the driver assembly hasa leading end to which is attached a removable bone anchor with a punchor tapered end for penetrating bone to form an anchor opening. The boneanchor delivery system device has the bone anchor releasable relative tothe driver assembly. The bone anchor driver assembly furthernon-rotatably holds the bone anchor, said bone anchor being releasablyheld on said driver assembly, and wherein after being driven into saidanchor opening, the driver assembly is withdrawn releasing said boneanchor fixed to said bone opening. In the preferred embodiment, the boneanchor has suture threads attached that are rotatably driven into thebone opening with the bone anchor.

In the preferred embodiment, the bone anchor driver assembly includes anelongated drive shaft fixed to the handle, the drive shaft having ahollow stem extending from the handle to the leading end. The boneanchor driver assembly drive shaft has the leading end with a tipportion extending from the leading end. The tip portion has a pair ofopenings for receiving sutures and at least one flat surface extendingalong the tip portion lengthwise to rotationally fix the bone anchor tothe drive shaft.

The bone anchor has a hollow end for receiving and being removablyattached on said tip portion. The bone anchor has at least one pair ofsuture openings, each pair of suture openings being within a threadchannel formed by two adjacent threads. The two openings of each pairare within 90 degrees of the other and extending into the hollow endopening. The bone anchor delivery system device further has a suturethreaded and looped through the at least one pair of suture openings,the suture extending from the bone anchor through one of the tipopenings internally through the hollow stem of the drive shaft of thebone anchor driver assembly.

The bone anchor delivery system device has a second pair of openings forreceiving a second suture. The second pair is within a thread channelformed by two adjacent threads being similarly spaced relative to thefirst pair, but on opposite sides of the bone anchor, and a secondsuture threaded through the second pair of openings and similarlyextending through the tip and the stem of the drive shaft. The boneanchor delivery system device has only a very short loop portion of eachthe sutures exposed externally in the thread channel. The exposed loopedportion extends at 90 degrees or less circumferentially around thechannel from the pair of openings in which the suture is held to thebone anchor. Each pair of the suture ends of the first or second sutureextend along only one side of the bone anchor through one opening on thetip to the stem, wherein all four suture ends extend to the handle andare wrapped around a recess groove in an end portion of the handle. Thebone anchor delivery system device further has a removable cover whereinsaid recess groove holds the suture ends and the removable coverencircles the sutures ends wrapped in said groove. The removable covercan be an elastomeric O ring.

The bone anchor can have two or more pairs of suture openings with eachopening of one pair radially or linearly aligned or radially or linearlyoffset relative to the openings of another pair.

DEFINITIONS

As used in this specification, the singular forms “a,” “an” and “the”include plural referents unless the context clearly dictates otherwise.Thus, for example, the term “a material” is intended to mean one or morematerials, or a combination thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention will be described by way of example and with reference tothe accompanying drawings in which:

FIG. 1 is a perspective view of the bone anchor delivery system deviceaccording to the present invention.

FIG. 2 is a side plan view of the device of FIG. 1.

FIG. 3 is an enlarged view of the handle portion.

FIG. 4 is a view of the leading end of the drive assembly showing thetip portion for receiving a bone anchor.

FIG. 4A is an enlarged side view of the tip portion showing the anchorin phantom.

FIG. 4B is a perspective view of FIG. 4A.

FIG. 4C is a cross sectional view taken along lines K-K of FIG. 4.

FIG. 4D is an end view taken along lines G-G of FIG. 4.

FIG. 5 is a perspective view of the bone anchor showing the sutures.

FIGS. 6A-6D show the preferred procedure or method of using the deviceof the present invention.

DETAILED DESCRIPTION OF THE INVENTION

With reference to FIG. 1, a perspective view of the bone anchor deliverysystem device 10 is shown. The device 10 has a handle assembly 40 and abone anchor driver assembly 20. The handle assembly 40 has an upperhandle portion 50 and a lower handle portion 60 as illustrated. Theupper or lower handle portion is rotatable relative to the other handleportion. A bone anchor driver assembly 20 is for rotatably driving abone anchor 12 into a hole in a bone is provided. The bone anchor driverassembly 20 is fixed to one of either the upper or lower handle portions50 or 60. As shown, the bone anchor driver assembly 20 is fixed to theupper handle portion 50 in the illustrated embodiment. Alternatively, itcould be fixed to the lower handle portion 60, if so desired. The handleassembly 40 during rotation of the handle portion fixed to the driverassembly 20 allows the other handle portion to be held non-rotatably tostabilize the device 10 during insertion of the bone anchor 12. Theupper handle portion 50 preferably has an impact end 52 for receivingblows from a mallet and the driver assembly 20 has a leading end or tipportion 22 having a removable bone anchor 12 with a punch tip 14 with atip portion 22 positioned on a sharpened metal pointed tip 25 forpenetrating bone to form the anchor opening. The bone anchor 12preferably is releasable relative to the driver assembly 20. As shown,the bone anchor driver assembly 20 non-rotatably holds the bone anchor12. This is accomplished by providing a flat 23 at the leading end ortip portion 22 of a drive shaft 21 included as part of the driverassembly 20, as shown in FIG. 4A. When the bone anchor 12 is driven intosaid bone anchor opening, the driver assembly 20 is withdrawn releasingthe bone anchor 12 fixed to the bone opening. The bone anchor 12preferably has suture threads attached that are rotatably driven intothe bone opening via the driver shaft 21.

With reference to FIG. 4, a side or plan view is shown at the anchor 12end of the device 10. In the preferred embodiment, the device 10 has thebone anchor 12 having at least one pair 14 of holes 14A, 14B; as shownin FIGS. 4A-4D, two pairs 14, 16 having holes 14A, 14B and 16A, 16B.These holes 14A, 14B are in a channel 13 between two adjacent threads 15and extend circumferentially 90 degrees or less within the channel 13 sothat the openings 14A and 14B are both on one side of the screw threads15 of the bone anchor 12 and openings 16A, 16B within the other pair 16are within an opening side of the screw threads 15 of the bone anchor12. As further illustrated, in FIG. 2, suture 6 can be looped throughthe openings 14A, 14B such that both ends 6A, 6B of the suture 6 extendthrough a hollow opening 12A in the anchor 12. The bone anchor 12 isillustrated in the perspective view of FIG. 5. These sutures 6 extendthrough the openings 14A, 14B into the hollow opening 12A in the boneanchor 12 that is adapted to fit onto the tip portion 22 of the leadingend of the drive shaft 21. The sutures 6 extend through the anchoropenings 14A, 14B and 16A, 16B into opening 12A and into openings 22A inthe leading end tip portion 22. These openings 22A are for receiving thesutures 6. The tip portion 22 further has at least one flat surface 23extending along the tip 22 lengthwise to rotationally fix the boneanchor 12 to the drive shaft 21. The sutures 6 when positioned into thepair of openings 14, 16 within the channel 13 form a loop 6L that areexternally exposed only within a very short region within one pair ofthreads 15 such that the exposed portion extends less than 90 degreesaround the circumference of the bone anchor channel 13. Both ends 6A, 6Bof the sutures 6 are then fed through one of the openings 22A in the tip22 and extend up a hollow stem opening 21A of the drive shaft 21 upwardsand through the drive shaft 21 which is fixed to the upper handleportion 50 as illustrated. The sutures 6 extend through a vertical slot55 to an end 52 of the handle assembly 40. The end 52 of the handleportion has a recessed groove 53 between the impact end surface 54 ofthe end 52 of the upper handle portion 50. It is in this recessed groove53 that the sutures 6 extend upward through the vertical slot 55 and arewrapped about the recessed groove 53 several times thereby positioningthe sutures 6 in such a fashion that they are completely internal of thedevice 10 within the handle assembly 40. Preferably, the suture ends 6A,6B are then covered by a cover 30 that is preferably elastomericstretching over the sutures 6 and holding them in place. As shown, thecover 30 is an O Ring 30 adapted to fit in the recessed groove 53 andhold the sutures 6A, 6B ends in place. The bone anchor 12 can have twoor more pairs of suture openings 14, 16 with each opening of one pairradially or linearly aligned or radially or linearly offset relative tothe openings of another pair.

With respect to FIGS. 1, 2 and 4A-4D, the bone anchor driver assembly 20by having an elongated drive shaft 21 affixed to the handle assembly 40has a long hollow stem opening 21A can accommodate a substantial lengthof sutures 6. Preferably, the second pair 16 of openings 16A, 16B on thebone anchor 12 are provided in an opposite side channel 13. The twopairs of openings 14, 16 again extend into the hollow end 12A of thebone anchor 12 such that a second pair of sutures 6 can be loopedthrough the openings 16A, 16B into the hollow ends 12A of the boneanchor 12 extend through a second opening 22B in the tip 22 andextending up through the hollow stem opening 21A of the drive shaft 21.These sutures 6 having ends 6C, 6D can be used in combination with theother suture ends 6A, 6B so that four threads of suture 6 extend throughthe handle assembly 40 and are wrapped in the recessed groove 53 aspreviously discussed.

As illustrated in FIGS. 6A-6D, on insertion of the bone anchor 12 into abone, the surgeon will take the device 10, find the position in which hewants to pierce the bone 2 creating a bone opening 3 and then take amallet and impact the end surface 54 of the device such that the boneanchor 12 penetrates and initiates the hole 3 deeper into the inner bonetissue 4. Once the hole 3 is initiated, the bone anchor 12 can then berotatably threaded into the bone opening 3 until the top of the boneanchor 12 is flush with the bone 2. When this occurs, the surgeon cansimply pull the device 10 off of the leading end tip portion 22 leavingit in the bone opening 3 and the sutures 6 can then be pulled throughthe device 10 and left exposed out of the end of the bone anchor 12. Inthis fashion, the surgeon can manipulate the entire device 10 by holdingone of the lower non-rotating handle portion 60 as he rotates the upperhandle portion 50 to rotate the fixed drive shaft 21 and drive the boneanchor 12 into the bone opening 3. This is accomplished with only a verysmall portion of the suture 6 being exposed at the loops 6L which isonly exposed within one pitch of the thread 15 within a distanceoccupying less than 90 degrees around the circumference of the channel13 formed between the two adjacent threads 15. The suture opening pairs14, 16 by being provided in pairs on each side of the bone anchor 12provide secure sets of suture ends 6A-6D that can attach ligament orother soft tissue during a bone or knee, shoulder repair.

As further illustrated in FIGS. 4-4D, in the preferred embodiment, thebone anchor 12 actually has a hollow opening 12A extending all the waythrough the bone anchor 12 and the drive shaft 21 includes a sharpenedmetal pointed tip 25 and extending partially through the bone anchor 12.This is believed important in that it helps to locate the device 10relative to the opening 3 to be made and provides a secure metalpenetrating punch tip 25 to assist the bone anchor 12 during itsinsertion and forming of the bone hole opening 3. As illustrated, byapplying pressure on the handle assembly 40, the bone anchor 12 can thenbe pressed into the bone 2 as it is being rotated, thereby creating avery tight compression fit. Due to the fact that the sutures 6 are onlyexposed over a short area, it is important to note that sutures 6 willbe held in place and not pulled or cut by any threads 15 of the anchor12 because the exposed loops 6L do not extend over any of the externalportions of the threads 15, but are rather held within a tightconstrained area within a single channel 13 on each side of the boneanchor 12. By having the sutures 6 contained almost entirely except forthe loops 6L within the bone anchor delivery device 10, there are nosuture ends or other suture threads that are exposed external of thedevice 10 until the device 10 is pulled from the bone anchor 12. Oncethis occurs, long lengths of sutures are provided from each pair ofopenings 14, 16. These sutures 6 will be used to tie off any softtissue, ligaments or cartilage that are being attached to the bone. Inthis fashion, the delivery system device 10 creates a very simple andefficient way in which the sutures 6 can be secured internally of thebone anchor 12 without creating any cumbersome knotting or loops thatcould interfere with threads or the holding of the bone anchor 12.

Variations in the present invention are possible in light of thedescription of it provided herein. While certain representativeembodiments and details have been shown for the purpose of illustratingthe subject invention, it will be apparent to those skilled in this artthat various changes and modifications can be made therein withoutdeparting from the scope of the subject invention. It is, therefore, tobe understood that changes can be made in the particular embodimentsdescribed, which will be within the full intended scope of the inventionas defined by the following appended claims.

What is claimed is:
 1. A bone anchor delivery system device comprises: ahandle; an elongated drive shaft fixed to the handle, the drive shafthaving a hollow stem extending from the handle to a leading end, theleading end having a tip portion, the tip portion having a pair ofopenings for receiving sutures and at least one flat surface extendingalong the tip portion lengthwise to rotationally fix a bone anchor tothe drive shaft; a bone anchor having a hollow end opening forattachment on said tip portion, the bone anchor having a first pair ofsuture openings, the first pair of suture openings being within a threadchannel formed by two adjacent threads, the openings of the first pairbeing within 90 degrees of the other and extending into the hollow endopening; a suture threaded and looped through the first pair of sutureopenings, the suture extending from the bone anchor through one of theopenings of the tip portion internally through the hollow stem; andwherein the bone anchor has a second pair of openings for receiving asecond suture, the second pair being within the thread channel formed bytwo adjacent threads being similarly spaced relative to the first pair,but on opposite sides of the bone anchor, and the second suture threadedthrough the second pair of openings and similarly extending from thebone anchor through the opposite opening of the tip portion internallythrough the hollow stem, wherein only a loop portion of each of thesutures is exposed externally in the thread channel, the exposed loopportion extending 90 degrees or less circumferentially externally aroundthe channel from which the suture is held to the bone anchor and whereinthe first and second sutures each have first and second ends and each ofthe suture ends extend along only one side of the anchor through saidpair of openings on the tip portion to the stem, wherein all four sutureends extend to the handle and are wrapped around a recess groove in anend portion of the handle.
 2. The bone anchor delivery system device ofclaim 1 further comprises a removable cover wherein said recess grooveholds the suture ends and the removable cover encircles the suture endswrapped in said groove.
 3. The bone anchor delivery system device ofclaim 2 wherein the removable cover is an elastomeric O ring.
 4. Thebone anchor delivery system device of claim 1 wherein the bone anchorhas the two pairs of suture openings, each opening of one pair beingradially aligned with an opening of another pair.
 5. The bone anchordelivery system device of claim 1 wherein the bone anchor has the twopairs of suture openings, each opening of one pair being radially offsetrelative to the openings of another pair.
 6. The bone anchor deliverysystem device of claim 1 wherein the bone anchor has the two pairs ofsuture openings, each opening of one pair being linearly aligned with anopening of another pair.
 7. The bone anchor delivery system device ofclaim 1 wherein the bone anchor has the two pairs of suture openings,each opening of one pair being linearly offset relative to the openingsof another pair.
 8. A bone anchor delivery system device comprises: ahandle assembly having an upper handle portion and a lower handleportion, the upper and lower handle portions being rotatable relative tothe other; a bone anchor driver assembly for rotatably driving a boneanchor, the bone anchor driver assembly being fixed to one of said upperor lower handle portions, the driver assembly having an elongated driveshaft fixed to the handle, the drive shaft having a hollow stemextending from the handle to a leading end, the leading end having a tipportion, the tip portion having a pair of openings for receiving suturesand at least one flat surface extending along the tip portion lengthwiseto rotationally fix a bone anchor to the drive shaft, the bone anchorhaving a hollow end opening for attachment on said tip portion, the boneanchor having a first pair of suture openings, the first pair of sutureopenings being within a thread channel formed by two adjacent threads,the openings of the first pair being within 90 degrees of the other andextending into the hollow end opening, a suture threaded and loopedthrough the first pair of suture openings, the suture extending from thebone anchor through one of the openings of the tip portion internallythrough the hollow stem, and wherein the bone anchor has a second pairof openings for receiving a second suture, the second pair being withinthe thread channel formed by two adjacent threads being similarly spacedrelative to the first pair, but on opposite sides of the bone anchor,and the second suture threaded through the second pair of openings andsimilarly extending from the bone anchor through the opposite opening ofthe tip portion internally through the hollow stem, wherein only a loopportion of each of the sutures is exposed externally in the threadchannel, the exposed loop portion extending 90 degrees or lesscircumferentially externally around the channel from which the suture isheld to the bone anchor and wherein the first and second sutures eachhave first and second ends and each of the suture ends extend along onlyone side of the anchor through said pair of openings on the tip portionto the stem, wherein all four suture ends extend to the handle and arewrapped around a recess groove in an end portion of the handle; andwherein rotation of the handle portion fixed to the driver allows theother handle portion to be held non-rotatably for stabilization of thedevice.
 9. The bone anchor delivery system device of claim 8 wherein theupper handle portion is fixed to the driver assembly.
 10. The boneanchor delivery system device of claim 8 wherein the upper handleportion has an impact end for receiving blows from a mallet and thedriver assembly has a leading end having the bone anchor positioned on asharpened metal pointed tip for penetrating bone to form an anchoropening.
 11. The bone anchor delivery system device of claim 10 whereinthe bone anchor is releasable relative to the driver assembly.
 12. Thebone anchor delivery system device of claim 11 wherein the bone anchordriver assembly further non-rotatably holds the bone anchor, said boneanchor being releasably held on said driver assembly, and wherein afterbeing driven into said anchor opening, the driver assembly is withdrawnreleasing said bone anchor fixed to said bone opening.
 13. The boneanchor delivery system device of claim 12 wherein the bone anchor hasthreads and is rotatably driven into the bone opening.
 14. The boneanchor delivery system device of claim 8 further comprises a removablecover wherein said recess groove holds the suture ends and the removablecover encircles the suture ends wrapped in said groove.